BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE

    K Number: K080050 · Decision May 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
    K Number
    K080050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spirus Medical, Inc.
    Date Received
    January 8, 2008
    Decision Date
    May 6, 2008
    Product Code
    FED
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Spirus Medical, Inc.

    K Number Device Name
    K080042 SPIRUS MEDICAL SURGICAL INSTRUMENT
    K062805 MODIFICATION TO ENDO-EASE
    K060235 ENDO-EASE ENDOSCOPIC OVERTUBE
    K052084 ENDO-EASE ENDOSCOPIC OVERTUBE